Specific Advanced Solid TumorsPhase 1NCT01970553
Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors
A Phase 1 study testing lurbinectedin (PM01183) and Gemcitabine in people with Specific Advanced Solid Tumors, run by PharmaMar at 3 sites in 2 countries.
Trial summary
Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Specific Advanced Solid Tumors
- What is being tested?
- lurbinectedin (PM01183) and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily written informed consent
- Age: between 18 and 75 years (both inclusive)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Life expectancy ≥ 3 months
- Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors:
- Breast cancer
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- Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas)
- Stromal uterine sarcomas
- Non-small cell lung cancer (NSCLC)
- Platinum-refractory or relapsed germ cell tumors
- Adenocarcinoma of the exocrine pancreas
- Biliary tract adenocarcinoma
- Adenocarcinoma or carcinoma of unknown primary site
- Advanced or unresectable mesothelioma
- At least three weeks since the last anticancer therapy,including radiation therapy (RT)
- Adequate bone marrow, renal, hepatic, and metabolic function
- Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiple-gated acquisition (MUGA) within normal range (according to institutional standards).
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment.
Who cannot join
- Concomitant diseases/conditions:
- History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
- Symptomatic or any uncontrolled arrhythmia
- Ongoing chronic alcohol consumption, or cirrhosis
- Active uncontrolled infection.
- Known human immunodeficiency virus (HIV) infection.
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- Any other major illness that, in the Investigator's judgment
- Brain metastases or leptomeningeal disease involvement
- Men or women of childbearing potential who are not using an effective method of contraception
- Patients who have had radiation therapy in more than 35% of the bone marrow
- History of previous bone marrow and/or stem cell transplantation
- Prior treatment with gemcitabine-containing therapy for advanced disease
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital Universitario Madrid Sanchinarro
Madrid
Hospital Universitario Virgen del Rocio
Seville
About this study
Official title: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Gemcitabine in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors
Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.
- Conditions
- Specific Advanced Solid Tumors
- Being tested
- lurbinectedin (PM01183), Gemcitabine
- Keywords
- lurbinectedin, PM01183, tumors, cancer, Pharma Mar
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lurbinectedin (PM01183)Drug
lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials
GemcitabineDrug
1000 mg vial, powder for injectable solution
| Study group | Role | What they receive |
|---|---|---|
| lurbinectedin (PM01183) / gemcitabine | Experimental | Patients will consecutively receive the following on Days 1 and 8 q3wk (three weeks = one treatment cycle):
- Gemcitabine: intravenous infusion of 800 mg/m2/day over 30 minutes,
immediately followed by:
- PM01183: intravenous infusion over one hour at a starting dose of 2.5 mg/day, flat dose (FD), both on Days 1 and 8 every 3 weeks Receives: Drug: lurbinectedin (PM01183); Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Dose (RD)
The RD will be the highest dose level explored at which less than one third of evaluable patients experience a DLT during Cycle 1.
Measured: 19 months
Secondary outcomes (3)
Pharmacokinetics (PK) characterisation
The dose-exposure relationships for maximum plasma concentration (Cmax) and area under the curve (AUC) will be evaluated.
Measured: 19 months
Preliminary antitumor efficacy
To obtain preliminary information on the clinical antitumor activity of this combination in non-heavily pretreated selected solid tumor patients
Measured: 29 months
Pharmacogenomics (PGx)
to identify molecular markers whose expression may be associated with the clinical outcome of patients. These molecular markers might allow the identification of those patients who will benefit from PM01183 and gemcitabine treatment, thus improving the health care by an individualized medicine.
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio Szyldergemajn, MD, Study chair, Pharma Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970553
- Sponsor's protocol ID
- PM1183-A-004-10
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Gemcitabine in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01970553
- Acronym / sponsor ID
- PM1183-A-004-10
- Conditions
- Specific Advanced Solid Tumors
- Keywords
- lurbinectedin, PM01183, tumors, cancer, Pharma Mar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lurbinectedin (PM01183) / gemcitabine | Experimental | Drug: lurbinectedin (PM01183), Drug: GemcitabinePatients will consecutively receive the following on Days 1 and 8 q3wk (three weeks = one treatment cycle): - Gemcitabine: intravenous infusion of 800 mg/m2/day over 30 minutes, immediately followed by: - PM01183: intravenous infusion over one hour at a starting dose of 2.5 mg/day, flat dose (FD), both on Days 1 and 8 every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily written informed consent
- Age: between 18 and 75 years (both inclusive)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Life expectancy ≥ 3 months
- Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors:
Key exclusion criteria (12 listed)
- Concomitant diseases/conditions:
- Brain metastases or leptomeningeal disease involvement
- Men or women of childbearing potential who are not using an effective method of contraception
- Patients who have had radiation therapy in more than 35% of the bone marrow
- History of previous bone marrow and/or stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lurbinectedin (PM01183)lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials | Drug | lurbinectedin (PM01183) / gemcitabine |
| Gemcitabine1000 mg vial, powder for injectable solution | Drug | lurbinectedin (PM01183) / gemcitabine |
Primary outcome
Recommended Dose (RD)
Time frame: 19 months
The RD will be the highest dose level explored at which less than one third of evaluable patients experience a DLT during Cycle 1.
3 secondary outcomes
Pharmacokinetics (PK) characterisation
Time frame: 19 months
Preliminary antitumor efficacy
Time frame: 29 months
Pharmacogenomics (PGx)
Time frame: 29 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Szyldergemajn, MD study chair
Pharma Mar
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lurbinectedin (PM01183) and Gemcitabine in people with Specific Advanced Solid Tumors, run by PharmaMar at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Dose (RD) (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.